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Weight loss technology for people with treated type 2 diabetes: a randomized controlled trial.

ABSTRACT: BACKGROUND:The prevalence of type 2 diabetes is increasing in worldwide despite the development of new treatment methods. Aim of the study was to evaluate a weight loss method on body composition, glycemic, lipid and hormone profiles, blood pressure and reactive oxygen species in people with treated type 2 diabetes. METHODS:A 24-week open, prospective, randomized, controlled clinical trial including 272 adult patients with treated type 2 diabetes was performed. The patients were divided in two groups: Main group consisted of 208 patients who followed a method including a calorie restriction diet and optimal physical activity; Control included 64 patients who received conventional drug treatment with weight loss. Main Outcome Measures were weight loss, fasting glucose and 2-hour oral glucose tolerance test (OGTT), HbA1c. Secondary endpoints were blood pressure, lipid and insulin blood levels. RESULTS:At 24 weeks, patients in Main weight lost between 8-18 kg (10-21%); their body mass index significantly decreased (-4.2 kg/m2) as well as their waist circumference (-13 cm) compared to Control. In Main weight loss was achieved fatty mass reduction. In Main fasting glucose and OGTT, HbA1c, blood pressure, reactive oxygen species decreased significantly, whereas hemoglobin levels and heel bone mineral density increased. In Main blood insulin levels decreased by 72.0%, cortisol levels decreased by 40.7%, while testosterone levels in men increased by 2.4 times from baseline. The application of the weight loss method led to a decrease in drug doses leading to their complete withdrawal. CONCLUSIONS:The results of this study show the beneficial role of a weight loss method in improving glycemic, lipid and hormone profiles, electrolyte and biochemical indices, blood pressure, reactive oxygen species and bone mineral density in patients with treated type 2 diabetes. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT02503865. Retrospectively registered November 2015.

SUBMITTER: Oshakbayev K

PROVIDER: S-EPMC5286692 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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Weight loss technology for people with treated type 2 diabetes: a randomized controlled trial.

Oshakbayev Kuat K Dukenbayeva Bibazhar B Togizbayeva Gulnar G Durmanova Aigul A Gazaliyeva Meruyert M Sabir Abdul A Issa Aliya A Idrisov Alisher A

Nutrition & metabolism 20170131

<h4>Background</h4>The prevalence of type 2 diabetes is increasing in worldwide despite the development of new treatment methods. Aim of the study was to evaluate a weight loss method on body composition, glycemic, lipid and hormone profiles, blood pressure and reactive oxygen species in people with treated type 2 diabetes.<h4>Methods</h4>A 24-week open, prospective, randomized, controlled clinical trial including 272 adult patients with treated type 2 diabetes was performed. The patients were d ...[more]

PMID: 28163748

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Project description:BACKGROUND:Rising obesity levels remain a major public health concern due to the clear link with several comorbidities such as diabetes. Diabetes now affects 6% of the UK population. Modest weight loss of 5% to 10% has been shown to be associated with significant reductions in blood sugar, lipid, and blood pressure levels. Men have been shown to be attracted to programs that do not require extensive face-to-face time commitments, illustrating the potential audience available for health behavior change via the Web. OBJECTIVE:The objective of our study was to evaluate the feasibility and acceptability of a Web-based weight loss intervention in men with type 2 diabetes. METHODS:We conducted a pilot, parallel 2-arm, individually randomized controlled trial with embedded process evaluation. Participants were randomly assigned in a one-to-one ratio to the usual care group or the 12-month Web-based weight loss intervention, including dietitian and exercise expert feedback. Face-to-face recruitment and assessment were performed by the researcher unblinded. Data collected included weight, height, body mass index (BMI), and waist circumference, together with an audit trail of eligibility, recruitment, retention, and adherence rates. A process evaluation (website use data and qualitative interviews) monitored adherence, acceptability, and feasibility of the intervention. RESULTS:General practice database searches achieved the recruitment target (n=61) for the population of men with type 2 diabetes, of whom 66% (40/61) completed 3-month follow-up measurements. By 12 months, the retention rate was 52% (32/61), with 12 of the 33 men allocated to the intervention group still active on the website. The intervention was seen as acceptable by the majority of participants. We gained insights about acceptability and use of the website from the parallel process evaluation. CONCLUSIONS:Recruitment to the Web-based weight loss intervention was successful. Results are descriptive, but there were positive indications of increased weight loss (in kilograms and as a percentage), and reduced waist circumference and BMI for the intervention group from 3 to 12 months, in comparison with control. This research adds to the evidence base in relation to incorporating a Web-based weight loss intervention within the UK National Health Service (NHS). NHS weight loss services are struggling to provide sufficient referrals. Therefore, alternative modes of delivery, with the potential to reduce health professional input and time per patient while still enabling individual and tailored care, need to be investigated to identify whether they can be effective and thus benefit the NHS. TRIAL REGISTRATION:International Standard Randomized Controlled Trial Number (ISRCTN): 48086713; http://www.isrctn.com/ISRCTN48086713 (Archived by WebCite at http://www.webcitation.org/6rO4xSlhI).

Project description:ObjectivesThe objectives of this study were to determine whether a technology-enhanced weight-loss program, using a home pet health technology ecosystem, is an effective tool in feline weight-loss management in multiple-cat households and to evaluate its impact on cat behavior.MethodsThe study was a prospective parallel unmasked block-randomized controlled trial comparing two weight loss intervention groups: (1) traditional group with dietary restriction alone (n = 9); (2) technology group that used dietary restriction, digital scales, smart feeders, activity monitors and pet treat cameras (n = 6). A 12-week weight-loss program of client-owned indoor-only two- or three-cat households with at least one overweight cat was conducted in Canada and the USA. Owner impressions of the technology, weight loss rates, smart feeder data, activity monitor data and health-related quality of life (HRQoL) were assessed.ResultsThe study was completed by 9/15 traditional group and 6/10 technology group cats. Dropouts were mainly due to owner issues unrelated to the study. The pet health technology ecosystem received favorable reviews (six responders). Smart feeders and home scales were perceived as valuable additions, while activity monitors and pet treat cameras were valued lower. The average weekly weight-loss rate (percent loss of initial body weight) was higher (P = 0.036) in the technology group (0.694%) than in the traditional group (0.175%). Although not associated with weight-loss rates, technology group cats trended toward grazing feeding patterns and decreased daily activity counts, while HRQoL increased, on average, for all cats.Conclusions and relevanceThis introductory investigation suggests that a technology-enhanced weight-loss program would be accepted by cat owners and may deliver advantageous outcomes in multiple-cat households, providing an effective and practical tool in feline weight-loss strategies that will continue to evolve as new technologies become available. It also illustrates the potential value of data gathered from home monitoring devices and digital diaries, providing deeper insights into pet behavior.

Project description:BACKGROUND:Intensive lifestyle interventions are effective in reducing the risk of type 2 diabetes, but the implementation of learnings from landmark studies is expensive and time consuming. The availability of digital lifestyle interventions is increasing, but evidence of their effectiveness is limited. OBJECTIVE:This randomized controlled trial (RCT) aimed to test the feasibility of a web-based diabetes prevention program (DPP) with step-dependent feedback messages versus a standard web-based DPP in people with prediabetes. METHODS:We employed a two-arm, parallel, single-blind RCT for people at high risk of developing diabetes. Patients with a hemoglobin A1c (HbA1c) level of 39-47 mmol/mol were recruited from 21 general practices in London. The intervention integrated a smartphone app delivering a web-based DPP course with SMS texts incorporating motivational interviewing techniques and step-dependent feedback messages delivered via a wearable device over 12 months. The control group received the wearable technology and access to the web-based DDP but not the SMS texts. As this was a feasibility study, the primary aim was to estimate potential sample size at different stages of the study, including the size of the target study population and the proportion of participants who consented, were randomized, and completed follow-up. We also measured the main outcomes for a full-scale RCT, namely, change in weight and physical activity at 6- and 12-month follow-ups, and secondary outcomes, including changes in the HbA1c level, blood pressure, waist circumference, waist-to-hip ratio, and lipid levels. RESULTS:We enrolled 200 participants: 98 were randomized to the intervention and 102 were randomized to the control group. The follow-up rate was higher in the control group (87/102, 85.3%) than in the intervention group (69/98, 70%) at 12 months. There was no treatment effect on weight at 6 months (mean difference 0.15; 95% CI -0.93 to 1.23) or 12 months (mean difference 0.07 kg; 95% CI -1.29 to 1.44) or for physical activity levels at 6 months (mean difference -382.90 steps; 95% CI -860.65 to 94.85) or 12 months (mean difference 92.64 steps; 95% CI -380.92 to 566.20). We did not observe a treatment effect on the secondary outcomes measured at the 6-month or 12-month follow-up. For the intervention group, the mean weight was 92.33 (SD 15.67) kg at baseline, 91.34 (SD 16.04) kg at 6 months, and 89.41 (SD 14.93) kg at 12 months. For the control group, the mean weight was 92.59 (SD 17.43) kg at baseline, 91.71 (SD 16.48) kg at 6 months, and 91.10 (SD 15.82) kg at 12 months. In the intervention group, the mean physical activity was 7308.40 (SD 4911.93) steps at baseline, 5008.76 (SD 2733.22) steps at 6 months, and 4814.66 (SD 3419.65) steps at 12 months. In the control group, the mean physical activity was 7599.28 (SD 3881.04) steps at baseline, 6148.83 (SD 3433.77) steps at 6 months, and 5006.30 (SD 3681.1) steps at 12 months. CONCLUSIONS:This study demonstrates that it is feasible to successfully recruit and retain patients in an RCT of a web-based DPP. TRIAL REGISTRATION:ClinicalTrials.gov NCT02919397; http://clinicaltrials.gov/ct2/show/NCT02919397.

Project description:BackgroundUp to 50 % of women with gestational diabetes mellitus (GDM) will receive a diagnosis of type 2 diabetes mellitus (T2DM) within a decade after pregnancy. While excess postpartum weight retention exacerbates T2DM risk, lifestyle changes and behavior modifications can promote healthy postpartum weight loss and contribute to T2DM prevention efforts. However, some women have difficulty prioritizing self-care during this life stage. Efficacious interventions that women can balance with motherhood to reduce T2DM risk remain a goal. The objective of the Moms in Motion study is to evaluate the efficacy of a simple, novel, activity-boosting intervention using ankle weights worn with daily activities during a 6-month postpartum intervention among women with GDM. We hypothesize that women randomized to the 6-month intensity-modifying intervention will (1) demonstrate greater weight loss and (2) greater improvement in body composition and biomarker profile versus controls.MethodsThis study will be a parallel two-arm randomized controlled trial (n = 160). Women will be allocated 1:1 to an ankle weight intervention group or a standard-of-care control group. The intervention uses ankle weights (1.1 kg) worn on each ankle during routine daily activities (e.g., cleaning, childcare). Primary outcomes include pre- and post-assessments of weight from Visit 2 to Visit 3. Secondary outcomes include body composition, glycemia (2-h, 75 g oral glucose tolerance test), and fasting insulin. Exploratory outcomes include energy expenditure, diet, and psychosocial well-being.DiscussionBeyond the expected significance of this study in its direct health impacts from weight loss, it will contribute to exploring (1) the mechanism(s) by which the intervention is successful (mediating effects of energy expenditure and diet on weight loss) and (2) the effects of the intervention on body composition and biomarkers associated with insulin resistance and metabolic health. Additionally, we expect the findings to be meaningful regarding the intervention's effectiveness on engaging women with GDM in the postpartum period to reduce T2DM risk.Trial registrationThe ClinicalTrials.gov Identifier, is NCT03664089 . The trial registration date is September 10, 2018. The trial sponsor is Dr. Sarah A. Keim.

Project description:BACKGROUND:Social networks influence obesity patterns, but interventions to leverage social incentives to promote weight loss have not been well evaluated. OBJECTIVE:To test the effectiveness of gamification interventions designed using insights from behavioral economics to enhance social incentives to promote weight loss. DESIGN:The Leveraging Our Social Experiences and Incentives Trial (LOSE IT) was a 36-week randomized, controlled trial with a 24-week intervention and 12-week follow-up. PARTICIPANTS:One hundred and ninety-six obese adults (body mass index ≥ 30) comprising 98 two-person teams. INTERVENTIONS:All participants received a wireless weight scale, used smartphones to track daily step counts, formed two-person teams with a family member or friend, and selected a weight loss goal. Teams were randomly assigned to control or one of two gamification interventions for 36 weeks that used points and levels to enhance collaborative social incentives. One of the gamification arms also had weight and step data shared regularly with each participant's primary care physician (PCP). MAIN OUTCOME MEASURES:The primary outcome was weight loss at 24 weeks. Secondary outcomes included weight loss at 36 weeks. KEY RESULTS:At 24 weeks, participants lost significant weight from baseline in the control arm (mean: - 3.9 lbs; 95% CI: - 6.1 to - 1.7; P < 0.001), the gamification arm (mean: - 6.6 lbs; 95% CI: - 9.4 to - 3.9; P < 0.001), and the gamification arm with PCP data sharing (mean: - 4.8 lbs; 95% CI: - 7.4 to - 2.3; P < 0.001). At 36 weeks, weight loss from baseline remained significant in the control arm (mean: - 3.5 lbs; 95% CI: - 6.1 to - 0.8; P = 0.01), the gamification arm (mean: - 6.3 lbs; 95% CI: - 9.2 to - 3.3; P < 0.001), and the gamification arm with PCP data sharing (mean: - 5.2 lbs; 95% CI: - 8.5 to - 2.0; P < 0.01). However, in the main adjusted model, there were no significant differences in weight loss between each of the intervention arms and control at either 12, 24, or 36 weeks. CONCLUSIONS:Using digital health devices to track behavior with a partner led to significant weight loss through 36 weeks, but the gamification interventions were not effective at promoting weight loss when compared to control. TRIAL REGISTRATION:clinicaltrials.gov Identifier: 02564445.

Project description:BACKGROUND:The prevalence of nonalcoholic fatty liver disease (NAFLD) reaches up to 30% in the Asian adult population, with a higher prevalence in obese patients. Weight reduction is typically recommended for patients at high risk or diagnosed with NAFLD, but is a challenge to achieve. OBJECTIVE:We aimed to evaluate the effect of a lifestyle intervention with a mobile app on weight loss in NAFLD patients. METHODS:This prospective randomized controlled trial included 108 adults with NAFLD confirmed by steatosis on ultrasound and a body mass index ?23 kg/m2 who were recruited from a fatty liver outpatient clinic. The patients were randomly allocated to either a control group (n=53) receiving standard care, consisting of dietary and lifestyle advice by a trained nurse, or an intervention group (n=55) utilizing the Nutritionist Buddy (nBuddy) mobile app in addition to receiving dietary and lifestyle advice by a dietitian. Body weight, alanine aminotransferase (ALT), aspartate aminotransferase (AST), waist circumference, and blood pressure were measured at baseline, and then at 3 and 6 months. Intention-to-treat and per-protocol analyses were used for statistical comparisons. RESULTS:The intervention group had a 5-fold higher likelihood (relative risk 5.2, P=.003, 95% CI 1.8-15.4) of achieving ?5% weight loss compared to the control group at 6 months. The intervention group also showed greater reductions in weight (mean 3.2, SD 4.1 kg vs mean 0.5, SD 2.9 kg; P<.001), waist circumference (mean 2.9, SD 5.0 cm vs mean -0.7, SD 4.4 cm; P<.001), systolic blood pressure (mean 12.4, SD 14.8 mmHg vs mean 2.4, SD 12.4 mmHg; P=.003), diastolic blood pressure (mean 6.8, SD 8.9 mmHg vs mean -0.9, SD 10.0 mmHg; P=.001), ALT (mean 33.5, SD 40.4 IU/L vs mean 11.5, SD 35.2 IU/L; P=.004), and AST (mean 17.4, SD 27.5 U/L vs mean 7.4, SD 17.6 IU/L, P=.03) at 6 months. CONCLUSIONS:Lifestyle intervention enabled by a mobile app can be effective in improving anthropometric indices and liver enzymes in patients with NAFLD. This treatment modality has the potential to be extended to a larger population scale. TRIAL REGISTRATION:Australian New Zealand Clinical Trials Registry ACTRN12617001001381; https://tinyurl.com/w9xnfmp.

Project description:BACKGROUND:The prevalence of type 2 diabetes is increasing in epidemic proportions in low- and middle-income countries. There is an urgent need for novel methods to tackle the increasing incidence of diabetes. The ubiquity of mobile phone use and access to Internet makes mobile health (mHealth) technology a viable tool to prevent and manage diabetes. OBJECTIVE:The objective of this randomized controlled trial is to implement and evaluate the feasibility, cost-effectiveness, and sustainability of a reality television-based lifestyle intervention program. This intervention program is delivered via a mobile phone app (mDiab) to approximately 1500 Android smartphone users who are adults at a high risk for type 2 diabetes from three cities in India, namely, Chennai, Bengaluru, and New Delhi. METHODS:The mDiab intervention would be delivered via a mobile phone app along with weekly coach calls for 12 weeks. Each participant will go through a maintenance phase of 6 to 8 months post intervention. Overall, there would be 3 testing time points in the study: baseline, post intervention, and the end of follow-up. The app will enable individuals to track their weight, physical activity, and diet alongside weekly video lessons on type 2 diabetes prevention. RESULTS:The study outcomes are weight loss (primary measure of effectiveness); improvement in cardiometabolic risk factors (ie, waist circumference, blood pressure, glucose, insulin, and lipids); and improvement in physical activity, quality of life, and dietary habits. Sustainability will be assessed through focus group discussions. CONCLUSIONS:If successful, mDiab can be used as a model for translational and implementation research in the use of mHealth technology for diabetes prevention and may be further expanded for the prevention of other noncommunicable diseases such as hypertension and cardiovascular diseases. TRIAL REGISTRATION:Clinical Trials Registry of India CTRI/2015/07/006011 http://ctri.nic.in/Clinicaltrials/pdf_generate.php? trialid=11841 (Archived by WebCite at http://www.webcitation.org/6urCS5kMB).

Dataset Information

Weight loss technology for people with treated type 2 diabetes: a randomized controlled trial.

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Weight loss technology for people with treated type 2 diabetes: a randomized controlled trial.

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